Using FAZA-PET/MRI to measure hypoxia in sarcoma patients
A Prospective Study of Hypoxia Imaging in Patients With Soft Tissue Sarcoma Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA) in Combination With MRI
This study is testing a new imaging method to see if it can help doctors measure low oxygen levels in tumors of patients with high-risk soft tissue sarcoma before and after their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03418818 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of FAZA-PET imaging combined with MRI to assess hypoxia in sarcoma tissues. It involves two arms: one for patients undergoing neo-adjuvant radiation or chemotherapy and another for those preparing for surgery. The study aims to measure the volume of hypoxic tumors in high-risk soft tissue sarcoma patients before and after treatment. Patients will be monitored for side effects following the FAZA PET/MRI scan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with high-risk soft tissue sarcomas or retroperitoneal sarcomas.
Not a fit: Patients with previous radiotherapy to the treatment area or other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment strategies for sarcoma patients by better understanding tumor hypoxia.
How similar studies have performed: While there have been few reports on using PET/MRI for sarcoma, the approach of measuring hypoxia with FAZA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with either: high-risk extremity STS (g2-3, \> 10 cm largest dimension, and leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumour, or undifferentiated pleomorphic sarcoma), or: high-risk RPS (g2-3, and leiomyosarcoma or dedifferentiated liposarcoma) 3. Intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the Sarcoma Site Group of PM 4. A negative serum pregnancy test within the two-week interval immediately prior to PET-MR imaging, for women of child-bearing age 5. Ability to provide written informed consent to participate in the study Exclusion Criteria: 1. Previous radiotherapy to intended treatment volumes. 2. Previous systemic therapy 3. Active malignancy other than sarcoma 4. Unable to remain supine for at least 60 minutes 5. Pregnancy or breast feeding 6. Age less than 18 years old 7. Failure to provide written informed consent 8. Contraindication for MR as per current institutional guidelines.
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.